Although accurate statistics on sexual assault are hard to come by, it is estimated that one out of every six American adult women has been the victim of an attempted or completed sexual assault in her lifetime. Considering the social stigma, shame, and fear associated with rape, it is not surprising that rape is the most under reported crime. Accordingly, semen detection tests, confirmatory tests and forensic DNA testing are indispensable tools for solving a case of rape and assault in order to bring perpetrators to justice.
Along these lines, five of the top ten reportable diseases in the United States are sexually transmitted diseases (“STDs”). Centers for Disease Control and Prevention (“CDC”) estimates of February 2013 show that there are about 20 million new sexually transmitted infections (“STIs”) in the United States each year, costing the American healthcare system nearly $16 billion in direct medical costs alone. CDC's data suggests that there are more than 110 million total (both new and existing) STIs among women and men across the nation. Young people (ages 15-24) are particularly affected, accounting for half (50%) of all new STIs. Some of these STIs have the potential to cause serious health problems, especially if not diagnosed and treated early.
STIs remain a major public health challenge in the United States, more so among women, who often disproportionately bear the long-term consequences of STIs. Women are more at risk for STIs due to the large surface area and the thin lining of the vagina. Women are more likely to be asymptomatic for common STIs and also have a greater biological susceptibility to infections. Women are also more likely to confuse an STI with a tame yeast infection or to have internal symptoms that may go unnoticed. STIs such as gonorrhea and chlamydia can lead to pelvic inflammatory disease (“PID”) when left untreated. Chlamydia in particular can also cause asymptomatic infection of the fallopian tubes, and consequently, infertility. Furthermore, pregnant women have an increased risk of passing STIs to their babies, either during pregnancy or during vaginal birth.
Besides STIs, there are myriad health conditions that are important, not only to women's health, but also to long-term fertility management. Reproductive cancers such as cervical, ovarian, uterine, and endometrial are of particular concern as they are often asymptomatic and present in late stages of disease.
Many nutritional deficiencies such as folate, iron, and other vitamins are essential for the healthy development of the fetus, and anemia caused by deficiencies in these minerals can cause birth defects, allergy sensitizations, and preterm birth.
Many hormones that work in concert to provide the optimal environment for pregnancy and fertility can often become dysregulated and may prevent a woman from getting or staying pregnant. Dysregulation can also cause diseases such as endometriosis and polycystic ovarian syndrome that may prevent a woman from becoming pregnant.
Even during pregnancy there are many health factors that a woman can monitor to help reduce the risk for preterm birth and infections such as yeast infections and Strep B. Fetal Fribronectin, if found in vaginal secretions during 19-32 weeks of pregnancy can be indicative of a preterm birth.
A cascade of changes occur during perimenopause as women transition into their non-reproductive years that can be measured and provide information to women on what is going on in their bodies at a chemical level that may help inform them of health and lifestyle choices as they age.
Current blood-based diagnostic methods have reduced patient compliance because they require either a trip to an external facility, where a trained professional can perform venipuncture in a sterile environment, or a finger prick to collect a small aliquot of blood. Analysis of a blood sample is usually done in a laboratory by a different trained professional. Venipuncture in a doctor's office involves a non-trivial time commitment, travel and labor costs, and often psychological and physical pain that may prevent individuals from undergoing regular monitoring of blood-based health markers. Even finger pricks done at home can be psychologically daunting and are difficult to enforce on a regular basis. In addition, finger pricks produce only a small amount of blood and subsequently limit the types of diagnostics that can be run at home. The friction that blood acquisition, alone, introduces into the health-care system down regulates the vigor with which consumers proactively monitor their health.
Although other diagnostic techniques, such as the Papanicolaou (“Pap”) smear do not require a blood sample, they still require a trip to the doctor's office. Current vaginal swab technologies require a specific swab that is inserted into the vaginal cavity. The protocol of collecting specimens from the vaginal cavity using a traditional vaginal swab is very precise, and an inaccurate procedure can lead to loss of sample and unreliable identification of desired biomarkers. Because of this, a trained medical professional typically administers vaginal swab collections. Moreover, the United States Preventive Task Force (“USPTF”) currently recommends Pap smears only every three years. Even an annual checkup by an obstetrics and gynecology professional (“OB-GYN”) does not guarantee a gonorrhea/chlamydia screen, nor would it be ideal to detect a pathogen that can lead to inflammation of the genital tract within weeks. This screening frequency impairs the identification and diagnosis of asymptomatic infections in particular.
As such, none of the currently available technologies allows for collection and analysis of biological materials for STIs in one device, without the need for further expensive laboratory equipment and professionals. One example of a currently available technology includes a method for screening for human papillomaviruses (“HPV”), and, in particular, screening for human genital papillomaviruses that are associated with neoplasia such as cervical cancer, which is described in International Patent Application Publication No. WO 2008/089519 to Tynan et al. (“Tynan”). Tynan's methods focus in particular on distinguishing between different HPV types in a biological sample. However, Tynan does not provide a device and method for self-analysis of one's blood samples. Samples must still be sent to a laboratory for diagnosis.
A portable device for the collection, storage, transport, and separation of biological materials is described in U.S. Patent Application Publication No. 2013/0337439 to Nobre et al. (“Nobre”). The materials can later be used to detect the presence of pathogens in a laboratory. However, the techniques offered require the use of acquired skills as well as expensive and specialized equipment.
In another publication by Tabrizi et al., the results of conventional methods for the detection of STIs are compared with results of tampon-collected specimens analyzed by polymerase chain reaction (“PCR”) (J. Infect. Dis. 176:289-292, 1997). However, as with the portable device taught by Nobre, all post-collection analysis work was done in a laboratory setting using specialized equipment.
The need to develop acceptable, accurate, and available point-of-care (“POC”) tests for diagnosing sexually transmitted diseases (STDs) for all at-risk populations is significant. Stigma, privacy, and confidentiality issues make STDs/STIs optimal areas for POC tests at healthcare facilities and for over-the-counter assays performed at home.
Accordingly, there is a need for a medical system and method that solves these and other problems.